| Objective:Observe the clinical efficacy in the treatment of non-infectious uveitis between adalimumab injection combined with corticosteroid and corticosteroids alone.Methods:Prospective randomized controlled clinical study.Sixty patients(92 eyes)who attended the Second Affiliated Hospital of Nanchang University from May 2020 to July2021 and were diagnosed with non-infectious uveitis according to the international Standardized Uveitis Nomenclature Working Group(SUN)diagnostic criteria were collected.Informed consent was signed,and a random number table method was used to divide the patients into a combined group and a control group.Thirty cases(48 eyes)in the combination group were treated with adalimumab injection subcutaneously combined with oral corticosteroids,and 30 cases(44 eyes)in the control group were treated with oral corticosteroids alone.The data of best-corrected visual acuity,intraocular pressure,anterior chamber flash glow grading,vitreous opacity score,and central macular thickness were recorded during baseline,1 month,3 months,6 months,10 months after the first therapy,and the occurrence of adverse events was recorded,finally,the difference and efficacy between the two groups were compared according to the results comprehensively.Statistical analysis of the data was analyzed by software SPSS 26.0.Graph Pad Prism 8.0 software was used for plotting.Results:1.Baseline clinical characteristicsAmong the 60 patients included,the age range was from 10 to 69 years,with an average age of(45.3±15.2)years,with the greatest number of patients aging from 25 to 44 years,accounting for 40.0%.There were 24 cases(40.0%)in males and 36 cases(60.0%)in females.There were 32 cases(64 eyes)with both eyes(53.3%)and 28 cases(28 eyes,46.7%)with one eye among all patients.There was no statistically significant difference in age,gender,and monocular/binocular morbidity between the combined and control groups of patients(P>0.05).The top three disease types in all patients were Vogt-Koyanagi-Harada syndrome,unknown type of uveitis,and rheumatic disease with uveitis,accounting for 31.7%,28.3%,and 11.7%,respectively.There were 43 cases(71.7%)of chronic indolent type,10 cases(16.7%)of recurrent uveitis,and 7 cases(11.7%)of acute uveitis.In the anatomical location classification,there were 3 cases(5.0%)of intermediate uveitis,21cases(35.0%)of posterior uveitis,and 36 cases(60.0%)of total uveitis.2.Ophthalmic indicators trendsBCVA: BCVA in the combined group improved at every time point after treatment compared to before treatment(P<0.05),BCVA in the control group improved at every time point after treatment compared to before treatment except for 1 month(P<0.05).There was no significant difference in BCVA between the combined group and the control group before and after 1 month of treatment(P>0.05),and BCVA in the combined group was better than that in the control group after 3 months,6 months,and10 months of treatment(P<0.05).IOP: There was no statistically significant difference in the IOP of the combined group at each time point after treatment compared with that before treatment(P>0.05).The same situation occurred in the control group,and there was no statistically significant difference in the IOP of the two groups at each time point before and after treatment between groups(P>0.05).Anterior atrial flash glow grading: anterior atrial inflammation was significantly relieved at all time points after treatment in the combined group compared with that before treatment(P<0.05),and in the control group except 1 month,anterior atrial inflammation was significantly relieved at all time points compared with that before treatment(P<0.05).The differences in anterior chamber flash glow grading between the two groups after 3,6,and 10 months of treatment were statistically significant(P<0.05).VH score: Vitreous inflammation was better in the combined group than before treatment at all time points except 1 month(P<0.05).The vitreous inflammation was significantly better in the control group at 6 and 10 months after the starting treatment.(P<0.05),and and the difference in VH score between the two groups after 6 and 10 months of treatment was statistically significant(P<0.05).CMT: After 1 month,3 months,6 months and 10 months of treatment,CMT was significantly reduced compared with that before treatment in the combined group(P<0.05),and in the control group it was significantly reduced after 1 month,3 months,6 months,and 10 months of treatment compared with baseline(P<0.05),and there was a statistically significant comparison between the two groups of CMT at each time point after treatment(P<0.05).3.The efficiency and recurrence rateThe effective rate was 93.3% in the combined group and 86.7% in the control group,and the difference in effective rate between the two groups was not statistically significant(P>0.05).The recurrence rate was 10.0% in the combined group and 23.3%in the control group,and the recurrence rate between the two groups was statistically significant(P<0.05).4.Hormone volumeThe amount of oral hormone dosage in both the combination group and the control group showed a decreasing trend,and the magnitude of oral hormone reduction in the combination group was significantly greater than that in the control group(P<0.05).5.Adverse eventsThere was no significant difference in adverse reactions between the combination group and the control group(P>0.05).Conclusion:Adalimumab injection in combination with glucocorticoids and glucocorticoids alone are both effective regimens for the treatment of non-infectious uveitis,improving visual acuity,reducing anterior chamber and vitreous inflammation and reducing macular retinal oedema to varying degrees,but the overall efficacy of the combination is significantly better,and the combination has a lower recurrence rate,a lower hormone dose at the end of follow-up and a good relative safety profile. |
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